AZ lung cancer drug rejected in Scotland

AstraZeneca's lung cancer drug, Iressa, has not been accepted for use in Scotland by the Scottish Medicines Consortium

AstraZeneca's (AZ) lung cancer drug, Iressa (gefitinib), has not been accepted for use in Scotland by the Scottish Medicines Consortium (SMC).

AZ described the decision as a "setback for Scotland's lung cancer patients" but said "it is working with the SMC in order to reverse the decision".

The drug was rejected on the grounds that the "manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient".

The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) in Scotland regarding the use of medicines and new formulations of medicines that have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) or European Medicines Agency (EMA).

Gefitinib, a targeted oral therapy, has been shown to improve progression-free survival, and offers significant advantages over current chemotherapy treatments improving both quality of life and symptom control.

It is intended for use only for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients who test positive for EGFR mutation tumours. This is to ensure only patients most likely to benefit can be considered for treatment, with the hope of minimising the financial risk.

Despite this, and acknowledging the drug's benefits, the SMC did not approve the drug.

AZ noted that the SMC's decision was based on the list price of gefitinib though, as opposed to the Single Patient Access scheme (SPA) put forward by the company.

Under SPA, a single payment, which remains fixed no matter what the duration of treatment, is issued per NHS patient. The figure for this fee is based on the overall population of patients with EGFR mutations for which gefitinib would meet the cost-effectiveness requirements laid out by the SMC and the National Institute for Health and Clinical Excellence (NICE).

The SMC did not take the SPA scheme into account however, as the Patient Access Scheme Assessment Group (PASAG), the new body for evaluating patient access schemes for Scotland, deemed SPA 'not implementable' in Scotland.

AZ has said it is working with PASAG regarding this issue.

Dr Marianne Nicolson, consultant medical oncologist at Aberdeen Royal Infirmary said: "The failure to accept gefitinib is disheartening for people with NSCLC in Scotland. Gefitinib offers a major step forward in the treatment of NSCLC, as a medicine which is more effective and with fewer side effects than chemotherapy in patients with a particular feature in their lung cancer."

She continued: "However I am pleased to see that AstraZeneca and NHS Scotland are working together to clarify technical issues regarding the feasibility of implementing the SPA scheme in Scotland so patients can get access to this important treatment."

The advice offered by SMA applies only in Scotland and is independent of any recommendations from NICE, which will apply to patients in England and Wales.